The invention relates generally to cuff sizers for estimating the girth of a body passage and particularly to cuff sizers used in procedures for the implantation of artificial sphincters.
Incontinence is the inability to voluntarily control the discharge of excretory materials and is typically caused by physical, neurological or psychological traumas. Incontinence is a major medical problem that affects millions of people and extends across all age groups. Moreover, this condition often results in serious discomfort and embarrassment of the patient, often forcing those affected to withdraw from regular social activities.
To address and treat incontinence and to assist affected patients in returning to a degree of normalcy in this area, surgical processes and devices have been developed which are intended to restore the lost anatomical functions. Many of these surgical processes employ devices whose function it is to selectively occlude the affected body passage upon the desire of the patient. Inflatable fluid actuated artificial urinary sphincters (AUS) are one type of such known devices and their function is to selectively occlude the urethra. Fluid actuated artificial bowel sphincters (ABS) are another type of device and their function is to selectively occlude the anus.
Referring to FIG. 1, an example of a fluid actuated ABS 10 is illustrated. However, it should be noted that an AUS has a similar configuration. The ABS 10 includes an inflatable cuff 12 configured to surround and occlude the anus 14, a pressure regulating balloon 16 to store actuating fluid, and a control pump 18 to transfer the actuating fluid from the balloon 16 to the cuff 12 and from the cuff 12 to the balloon 16.
For a female patient, the pump 18 is implanted in the labia 20, and the balloon 16 is implanted in the abdomen such as the space of retzius. For a male patient, the pump may be implanted in the scrotum, and the balloon may be implanted in the abdomen such as the space of retzius.
The basic components of these devices are connected by fluid transmission lines 24, 26. One fluid transmission line 24 or conduit connects the cuff 12 with the pump 18, and the second fluid transmission line 26 or conduit connects the pump 18 with the balloon 16. The cuff 12 is inflated to occlude the anus 14 and deflated to allow the discharge of feces through the anus 14. Normally, the cuff 12 is maintained in an inflated (closed) position.
One of the difficulties associated with an inflatable fluid actuated sphincter is that the implanted cuff may be improperly sized for the particular anus or urethra due to the difficultiness of determining the anal or urethral girth during surgery. A cuff which is over-sized may lead to unreliable coaptation or closure of the anal or urethral tissue, thus defeating the purpose of implanting the cuff, while a cuff which under-sized may cause damage to the circumscribed tissue or unduly restrict the size of the cuffed passage. Thus, there exists a need for a device and method to assist the surgeons in a more accurate determination of the anal or urethral girth of a patient for selecting an appropriately sized cuff during the surgical procedure.
In accordance with the present invention, a locking cuff sizer for determing the size of a body passage is provided. The cuff sizer is particularly suited for properly sizing the anal or urethral girth during surgical implantation of an ABS or AUS device. In accordance with an illustrative embodiment of the present invention, the cuff sizer includes a flexible strip having first and second ends. A plurality of apertures are disposed between the first and second ends of the strip, and the plurality of apertures are aligned along a longitudinal axis of the strip. Indices of body passage circumference are disposed on the strip in association with each of the plurality of apertures. An adapter is disposed near the first end of the strip, and the adapter engages with one of the plurality of holes to lock the cuff sizer around the body passage.
The strip is inserted into a dissected tunnel around the body passage and manipulated such that the strip substantially surrounds the body passage. By securing the adapter onto one of the plurality of apertures, the cuff sizer is locked around the circumference of the body passage. Once xe2x80x9clockedxe2x80x9d, the surgeon may evaluate the tightness of the xe2x80x9clockedxe2x80x9d position by sliding the cuff sizer along the body passage. If the cuff sizer is overly tight or loose, it may be xe2x80x9cunlockedxe2x80x9d and another aperture may be selected. When the appropriate aperture is selected, measurement of the body passage may be observed by viewing the indicia in association with the appropriate aperture. After determining the correct cuff size, the cuff sizer is removed, and a correctly sized cuff is implanted into the patient.
To aid in the insertion, manipulation, and securement of the cuff sizer around the circumference of the body passage, the cuff sizer may include an introducer such as a flexible tubing having first and second ends, wherein the first end is connected to the adapter. The cuff sizer may be introduced into the dissected tunnel by first inserting the introducer through the dissected tunnel. The strip may then be drawn through the dissected tunnel by pulling the introducer. The cuff sizer may then be secured into its xe2x80x9clockedxe2x80x9d position by passing the second end of the introducer through the desired aperture and securing the adapter onto the appropriate aperture.
Other objects, features, and advantages of the present invention will become apparent from a consideration of the following detailed description.